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CFT1946

Phase 1

Solid Tumors | Small molecule | Oncology |C4 Therapeutics, Inc.|Last Updated: Nov 21, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment89

FDA Designations

No designations recorded

Clinical trial landscape

CFT1946 · 1 trial · 5 indications

Phase 1 1
NCT05668585A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid TumorsSolid Tumors
COMPLETED89 Analytics
PHASE1COMPLETED
A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors
Solid Tumors
NCT0566858589
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Study Endpoints

Primary Endpoints

Frequency and severity of AEs and SAEs
From enrollment until 30 days after completion of study treatment

Phase 1

Incidence of dose limiting toxicities (DLTs)
From enrollment until 28 days after first dose

Phase 1

Number of subjects with changes between baseline and post-baseline safety assessments based on safety laboratory results graded by CTCAE v5.0
From enrollment until 30 days after completion of study treatment

Phase 1

Frequency of dose interruptions and dose reductions
From enrollment until 30 days after completion of study treatment

Phase 1

Frequency of AEs leading to discontinuation of study treatment(s)
From enrollment until 30 days after completion of study treatment

Phase 1

Overall response rate (ORR)
Up to approximately 43 months

Phase 2 only according to RECIST v1.1 criteria

Disease control rate (DCR) at 3, 6, and 12 months
Up to 12 months

Phase 2

Duration of Response (DOR)
Up to approximately 43 months

Phase 2

Secondary Endpoints

Frequency and severity of AEs and SAEs
From enrollment until 30 days after completion of study treatment
Number of subjects with changes between baseline and post-baseline safety assessments based on safety laboratory results graded by CTCAE v5.0
From enrollment until 30 days after completion of study treatment
Frequency of dose interruptions and dose reductions
From enrollment until 30 days after completion of study treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1: Arm A: CFT1946EXPERIMENTALApproximately 40 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma, ATC)
Phase 1: Arm B: CFT1946 + trametinibEXPERIMENTALApproximately 28 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma)
Phase 2: Arm A1: CFT1946EXPERIMENTALApproximately 30 subjects with V600 melanoma or NSCLC (post BRAF inhibitor)
Phase 2: Arm B1: CFT1946 + trametinibEXPERIMENTALApproximately 20 subjects with V600 melanoma or NSCLC (post BRAF Inhibitor)
Phase 1: Arm C: CFT1946 + cetuximabEXPERIMENTALApproximately 30 subjects with CRC (post BRAF inhibitor)
Phase 2: Arm C1: CFT1946 + cetuximabEXPERIMENTALApproximately 40 subjects with CRC (post BRAF inhibitor)

Interventions

NameTypeDescription
CFT1946DRUGSpecified oral dose on specified day
TrametinibDRUGSpecified oral dose on specified day
CetuximabDRUGSpecified intravenous dose on specified day
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: 1. Subject (or legally authorized representative, where applicable) is willing and able to provide signed informed consent and can follow protocol requirements 2. Subject is ≥18 years of age at time of informed consent 3. Eastern Cooperative Oncology Group performance status of ...

Countries:United StatesFranceGermanySpainUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about CFT1946

What is CFT1946 used for?

CFT1946 is an investigational small molecule being developed for the treatment of solid tumors, including melanoma, non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and anaplastic thyroid cancer (ATC). It is designed for patients with BRAF V600 mutant solid tumors.

What does CFT1946 target?

CFT1946 targets BRAF V600 mutant solid tumors. It is being studied as a monotherapy and in combination therapy for patients with these specific genetic mutations.

Who makes CFT1946?

CFT1946 is being developed by C4 Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CCCC.

What phase is CFT1946 in?

CFT1946 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed to evaluate its safety, tolerability, and preliminary efficacy.

What clinical trials is CFT1946 in?

CFT1946 has been studied in a Phase 1 clinical trial (NCT05668585) that evaluated its safety, tolerability, and preliminary efficacy as monotherapy and combination therapy in subjects with BRAF V600 mutant solid tumors. The trial enrolled 89 participants and has been completed.

Is CFT1946 the same as any other drug?

CFT1946 is the primary name for this investigational drug. No alternative names have been reported for this compound.